Clinical Data Manager

Clinical Data Manager

PSI CRO

Sofia, Bulgaria

Responsibilities will include

• Track database set-up, testing, maintenance and data entry;
• Communicate with clients, project teams and vendors on data management matters;
• Review study documents, design and develop project specific guidelines and instructions;
• Design eCRF, Data Management and Data Validation Plans and test EDC databases;
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation;
• Code medical data;
• Track and report metrics leading to database lock;
• Coordinate the processing, dispatch and archiving of CRFs/queries;
• Maintain Clinical Data Management working files;
• Perform database QC checks, prepare and attend audits;
• Train site staff and project teams on CRF completion and data management topics.

Qualifications

• College/University degree (Life Science, Pharmacy degree is a plus);
• Prior experience with clinical or medical data;
• Full working proficiency in English;
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm) is desirable;
• Proficiency in MS Office applications;
• Organisational and time management skills;
• Ability to work independently and multi-task.

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Bulgaria      Clinical Data Management      Data, Programming and Statistics      On-site      PSI CRO